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McDermott Will & Emery

New HRSA 340B Program Resource Asserts Agency’s Position on “Patient” Definition

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On December 14, 2023, Health Resources & Services Administration (HRSA) announced a new resource on the 340B Program website compiling resources associated with the 340B Program definition of “patient.” The website is...more

Epstein Becker & Green

In Genesis Case, South Carolina District Court Scraps HRSA Interpretation of “Patient” Under 340B Statute

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On November 3, 2023, the United States District Court for the District of South Carolina issued its decision in the long-running dispute between Genesis Health Care Inc., a federally qualified health center and 340B-covered...more

McDermott Will & Emery

What Makes a Patient a “Patient”? Court Rejects Restrictive 340B Definition

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On November 3, 2023, the US District Court for the District of South Carolina issued a landmark order in Genesis Health Care, Inc. v. Becerra, a case analyzing the definition of a “patient” under the 340B Program Statute. The...more

McDermott Will & Emery

This Week in 340B: November 2023

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This weekly series provides brief summaries to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more

Foley Hoag LLP

District Court Invalidates 340B Patient Definition in Genesis Case, Raising Questions About Program Scope

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On Friday, November 3, 2023, the U.S. District Court for the District of South Carolina issued a long-awaited decision in Genesis Health Care, Inc. v. Becerra—a case dating back to 2017 contesting HRSA’s definition of...more

Quarles & Brady LLP

District Court Allows for Expanded Interpretation of Eligible Patient in Impactful 340B Program Ruling

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In a decision likely to send shockwaves through the 340B Program space, the United States District Court of South Carolina recently provided a favorable ruling to 340B-participating covered entities hoping to take a more...more

Bass, Berry & Sims PLC

Court Guts 340B Program “Patient” Definition, Opening Door to More 340B Use

Bass, Berry & Sims PLC on

On November 3, a federal district court issued a monumental decision endorsing an expansive view of who is a “patient” of a 340B program covered entity eligible to receive a 340B drug. In Genesis Healthcare, Inc. v. Becerra,...more

Quarles & Brady LLP

HRSA Notice Provides Clarity on 340B Child Site Registration Requirements

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After months of relative uncertainty, the Health Resources and Services Administration (HRSA) published a Notice confirming the end to a COVID-19 pandemic-era flexibility that allowed unregistered child sites to utilize 340B...more

McDermott Will & Emery

This Week in 340B: July 2023 #4

This weekly series provides brief summaries to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets on more than 40 340B cases to provide you with a quick...more

Zuckerman Spaeder LLP

Whither Insurance Coverage for Preventive Health Services? District Court Decision Striking Down Affordable Care Act’s Preventive...

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On May 15, 2023, the Fifth Circuit temporarily stayed a district-court ruling that struck down a key part of the Affordable Care Act (ACA). As a result of the stay, the ACA’s health insurance coverage requirements for...more

McDermott Will & Emery

This Week in 340B: February 2023

McDermott Will & Emery on

This weekly series provides brief summaries to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets on more than 40 340B cases to provide you with a quick...more

K&L Gates LLP

Health Care Triage: Genesis Healthcare and the 340B Program Patient Definition

K&L Gates LLP on

In this episode, Andrew Ruskin, Leah Richardson, and Victoria Hamscho analyze the U.S. Court of Appeals for the Fourth Circuit’s recent decision in Genesis Healthcare v. Becerra. They discuss its potential impact on the...more

McDermott Will & Emery

HRSA Filings in Genesis Shed Light on Definition of “Patient” for 340B Covered Entities

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A recent case before the US Court of Appeals for the Fourth Circuit addressed the issue of which persons qualify as “patients” of a 340B program participating entity (covered entity). Court-ordered filings in ongoing...more

Holland & Hart - Health Law Blog

Free COVID-19 Vaccines and Diagnostic Testing

Over a year after the declaration of a nationwide public health emergency due to the Coronavirus Disease 2019 (“COVID-19”) pandemic, providers are in a position to offer patients a variety of COVID-19 medical services,...more

Sheppard Mullin Richter & Hampton LLP

Maneuvers on the 340B Drug Pricing Program Battlefield: Duplicate Discounts and Contract Pharmacies

In a December 12, 2017 Advisory Board article, “The 340B drug pricing controversy, explained,” Scott Orwig wrote, “the 340B Drug Pricing Program is one of the most contentious issues in health care: Its critics say it ‘hurts...more

Baker Donelson

340B Drug Pricing Program: The Withdrawal of Mega Guidance and the Future of Patient Definition

Baker Donelson on

In the wake of a recent directive issued by the Trump administration to halt pending regulations and guidance while the new leadership conducts its own review, the Department of Health and Human Services, on January 30, 2017,...more

Pullman & Comley, LLC

Alert: Proposed 340B Drug Pricing Program Omnibus Guidance - Defines "Eligible Patient"

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On August 28, 2015, the Health Resources and Services Administration (“HRSA”) published the proposed 340B Drug Pricing Program Omnibus Guidance (“Omnibus Guidance”) which is intended to clarify for covered entities, such as...more

Mintz - Health Care Viewpoints

The Proposed 340B Guidance:  Who is the Biggest Loser?

We have now had more than 30 days to digest HRSA’s proposed 340B Drug Pricing Program Omnibus Guidance (“Proposed Guidance”), intended to clarify expectations and provide guidance on key issues in the 340B Program. There are...more

Robinson & Cole LLP

Health Law Pulse - October 2015

Robinson & Cole LLP on

The Health Resources and Services Administration (HRSA) recently issued proposed omnibus guidance (Omnibus Guidance) interpreting various provisions of the 340B Drug Pricing Program (340B Program). The 340B Program allows...more

King & Spalding

HRSA Publishes Proposed 340B Drug Pricing Program Omnibus Guidance - Comments Due to HRSA on or before Tuesday, October 27, 2015

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On Friday, August 28, 2015, the Health Resources and Services Administration (“HRSA” or “the Agency”) published in the Federal Register Notice of its proposed “omnibus” or “mega” guidance (“Proposed Guidance”) regarding...more

Baker Donelson

Drastic Changes in "Patient" Definition as HHS Releases the Long-Awaited Proposed 340B Omnibus Guidance

Baker Donelson on

After years of fits and starts, the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human Services (HHS) has finally released its proposed omnibus guidance for the 340B Drug Discount...more

Cooley LLP

Blog: HRSA 340B Drug Discount Program “Omnibus” Regulation Published – Comment Period Open Until October 2015

Cooley LLP on

On Friday, August 28, 2015, the U.S. Department of Health and Human Services (HHS) Health Resources and Services Administration (HRSA) proposed its long-awaited “Omnibus” regulation for the 340B Drug Discount Program in the...more

Pillsbury Winthrop Shaw Pittman LLP

340B Omnibus Guidance Would Significantly Narrow the Pool of Eligible Patients

New guidance from the Health Resources Services Administration (HRSA) clarifying certain definitions integral to the 340B Drug Pricing Program (“340B Program”) will significantly limit the number of patients eligible to...more

Polsinelli

340B Program Change on the Horizon? OMB Completes Review of the 340B Omnibus Guidance

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Safety-net providers, manufacturers, members of Congress, and other stakeholders have been tracking the status of the Health Resources and Services Administration’s (“HRSA”) draft 340B Omnibus Guidance closely as it promises...more

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